The invention relates generally to a spinal implant assembly for holding vertebral bones fixed relative to one another. More particularly, the invention relates to a longitudinal plate assembly having an adjustable length and two ends that each can be coupled to a body structure, such as a vertebral bone, for use in surgical procedures for stabilizing the relative motion of, or permanently immobilizing, the body structures.
The bones and connective tissue of an adult human spinal column consists of more than twenty discrete bones coupled sequentially to one another by a tri-joint complex which consist of an anterior disc and the two posterior facet joints, the anterior discs of adjacent bones being cushioned by cartilage spacers referred to as intervertebral discs. These more than twenty bones are anatomically categorized as being members of one of four classifications: cervical, thoracic, lumbar, or sacral. The cervical portion of the spine, which comprises the top of the spine, up to the base of the skull, includes the first seven vertebrae. The intermediate twelve bones are the thoracic vertebrae, and connect to the lower spine comprising the five lumbar vertebrae. The base of the spine includes the sacral bones (including the coccyx). The component bones of the cervical spine are generally smaller than those of the thoracic spine, which are in turn smaller than those of the lumbar region. The sacral region connects laterally to the pelvis. While the sacral region is an integral part of the spine, for the purposes of fusion surgeries and for this disclosure, the word spine shall refer only to the cervical, thoracic, and lumbar regions.
Referring now to FIGS. 1 and 2, a typical vertebral body is shown in a top view and a side view. The spinal cord is housed in the central canal 10, protected from the posterior side by a shell of bone called the lamina 12. The lamina 12 has three large protrusions, two of which extend laterally from the shell and are referred to as the transverse process 14. The third extends back and down from the lamina and is called the spinous process 16. The anterior portion of the spine comprises a set of generally cylindrically shaped bones which are stacked one on top of the other. These portions of the vertebrae are referred to as the vertebral bodies 20, and are each separated from the other by the intervertebral discs 22. Pedicles 24 are bone bridges which couple the anterior vertebral body 20 to the corresponding lamina 12 and posterior elements 14, 16.
The spinal column of bones is highly complex in that it includes over twenty bones coupled to one another, housing and protecting critical elements of the nervous system which have innumerable peripheral nerves and circulatory bodies in close proximity. In spite of these complications, the spine is a highly flexible structure, capable of a high degree of curvature and twist in nearly every direction.
Genetic or developmental irregularities, trauma, chronic stress, tumors, and disease are a few of the causes which can result in spinal pathologies for which permanent immobilization of multiple vertebral bodies may be necessary. A variety of systems have been disclosed in the art which achieve this immobilization by implanting artificial assemblies in or on the spinal column. These assemblies may be classified as anterior, posterior, or lateral implants. As the classification suggests, posterior implants are attached to the back of the spinal column, generally hooking under the lamina and entering into the central canal, attaching to the transverse process, or coupling through the pedicle bone. Lateral and anterior assemblies are coupled to the vertebral bodies.
The region of the back which needs to be immobilized, as well as the individual variations in anatomy, determine the appropriate surgical protocol and implantation assembly. The use of screw plate assemblies for stabilization and immobilization via lateral or anterior entrance is, however, common.
Because spinal injuries vary with regard to the number of vertebral bodies affected, the proximity of the affected vertebral bodies with respect to one another, and the proximity of the unaffected or stable vertebral bodies with respect to one another, it is necessary for the treatment of a given spinal injury to use a plate assembly having a length that can be used effectively to immobilize, with respect to one another, those vertebral bodies that must be so immobilized to achieve clinically desirable results. For example, depending on the spinal injury, it may be necessary to immobilize two adjacent vertebral bodies. Or, for example, it may be necessary to immobilize two vertebral bodies on either side of one or more unstable or damaged vertebral bodies. Potentially, each spinal injury therefore requires a plate assembly having a different length.
In addition, the vertebral bodies of the spine are not all equal in length or identical in shape. Some are smaller than others, and are therefore shorter and, for example, have smaller transverse processes, spinous processes, and/or smaller pedicles. Therefore, depending on the location of the spinal injury along the spine, it is again necessary to select a plate assembly having a length that can be used effectively to immobilize, with respect to one another, those vertebral bodies that must be so immobilized to achieve clinically desirable results. For example, in the cervical portion of the spine, the immobilization of two adjacent vertebral bodies will require a plate assembly of a given length, while the immobilization of two adjacent vertebral bodies in the lumbar region will typically require a plate assembly that is longer. And, of course, the selection of the plate assembly of appropriate length must take into account the specific location of the bone structures to which the a plate assembly will be coupled, as these specific locations vary depending on the spinal injury and the damage caused thereby.
Further, because the spine is routinely subject to high loads which cycle during movement, one of the primary concerns of physicians performing spinal implantation surgeries, as well as of the patients in whom the implants are placed, is the risk of screw pull-out. Screw pull-out occurs when the cylindrical portion of the bone which surrounds the inserted screw fails. A bone screw which is implanted perpendicular to the plate is particularly weak because the region of the bone which must fail for pull-out to occur is only as large as the outer diameter of the screw threads. It has been found that for pull-out to occur for a pair of screws which are angled inward, xe2x80x9ctoe nailedxe2x80x9d, or ones which diverge within the bone, the amount of bone which must fail increases substantially as compared to pairs of screws which are implanted in parallel along the axis that the loading force is applied. It has, therefore, been an object of those in the art to provide a screw plate assembly which permits the screws to be entered into the vertebral body at angles other than 90 degrees.
A great concern, however, with screws being implanted in the anterior portion of the spine, most particularly in the cervical spine, is that there are important internal tissue structures which, because of their proximity to the implant, may be damaged by a dislocated screw. In the cervical spine, the esophagus is located directly in front of the anterior surface of the vertebral body, and therefore, in potential contact with an implanted cervical plate assembly. Breaches of the esophageal wall permit bacterial contamination of the surrounding tissues, including the critical nerves in and around the spinal cord. Such contamination can be fatal. Because screw pull-out represents one of the largest risks of esophageal perforation, it has been an object of those in the art to produce a cervical screw plate assembly having a locking means which couples, not only the plate assembly to the bone, but locks the screw to the plate assembly. In such a design, it is intended that, even if the bone holding the screw fails, the screw will not separate from the plate assembly.
In addition to pull-out, however, it has been observed that if the screw plate assembly includes screw heads which protrude beyond the exterior surface of the plate assembly, long term wearing of surrounding tissues may occur, leading to the development of abscesses and holes, which, once again, can have grave consequences. With respect to cervical plate assemblies, which are necessarily thin, on the order of a few millimeters, unless the system is designed to specifically accommodate non-perpendicular screw-in directions, the heads of the screws which are desirably toe-nailed in are a considerable risk.
Similar concerns exist in the thoracic and lumbar regions with respect to anterior and lateral fixation implants as their are proximally located organs as well as a plurality of major blood vessels which may be compromised by either catastrophic screw pull-out and/or long term wearing of non-flush surface protrusions.
One screw plate design which has been offered to provide physicians and patients with a reduced risk of pull-out or damage to proximal tissues is the Orion(trademark) Anterior Cervical Plate System of Sofamor Danek USA, 1800 Pyramid Place, Memphis, Tenn. 38132. The Orion(trademark) system teaches a plate having two pair of guide holes through which the screws are inserted to fix the plate to the vertebral body. The plate further includes external annular recessions about each of the guide holes which are radially non-symmetric in depth. More particularly, the annular recessions serve as specific angle guides for the screws so that they may be inserted non-perpendicularly with respect to the overall curvature of the plate. In addition, the Orion(trademark) plate includes an additional threaded hole disposed between each of the pairs of guide holes so that a corresponding set screw may be inserted to lock the bone screws to the plate.
Although the Orion(trademark) system achieved certain advantages over prior cervical screw plate assemblies, it is not without failures. Specifically, a given plate can accommodate only one screw-in angulation per hole, preferably in accordance with the angle of the annular recession. This is undesirable, in that physicians often must inspect the vertebral bodies during the implantation procedure before making the decision as to which screw-in angle is the ideal. By forcing the physician to chose from a limited set of angles, it is unavoidable that physicians will be forced to implant plates having screws which were positioned non-ideally. While providing a variety of plates having different angle guide holes and annular recession orientations is possible, the complexity and expense of providing a full spectrum of plates available in the operating room for the surgeon to choose from is undesirable. It is a failure of the system that one plate cannot accommodate a variety of different screw-in angles.
It is an additional failure of the system that an extra set screw is required to lock the screw to the plate. Plates for use in the cervical spine are very thin, and if the screw head already rests in an annular recess, and there is to be enough room for the head of the set screw to rest on top of the head of the bone screw, the thickness of the remaining plate must be reduced even further. The thinner the plate is at the load bearing points--the guide holes--the weaker the plate is overall.
It is a further failure of the system that one plate cannot accommodate a variety of lengths. Specifically, a given plate can accommodate only one length, preferably the length that is needed for the specific injury. This is undesirable, in that physicians often must inspect the vertebral bodies during the implantation procedure before making the decision as to which plate length is the ideal. By forcing the physician to chose from a limited set of lengths, it is unavoidable that physicians will be forced to implant plates having a length that is non-ideal for the application. This problem is compounded by the limited set of angles discussed above, in that the physician may be forced to use an angle other than the one most clinically appropriate simply because the fixed length of the plate, while being the closest clinically appropriate length available, is slightly too long or too short to allow the desired angle to be used. While providing a variety of plates having different lengths is possible, the complexity and expense of providing a full spectrum of plates available in the operating room for the surgeon to choose from is undesirable.
While the preceding discussion has focused on a specific cervical screw plate system and its failures, the same failures apply to the art of vertebral immobilizing screw plate systems which are presently available as well. There are no presently available screw plate assemblies which present a flush surface and provide for means of preventing both screw pull-out from the bone and screw backout from the plate, while simultaneously providing for a wide range of angulation for the bone screws and for a wide range of plate lengths.
An additional concern for physicians who implant screw plates for spinal fixation is proper alignment for pre-drilling of the holes into which the bone screws are driven to hold the plate. As suggested above with respect to the angulation of the annular recesses of the Orion(trademark) system, the process of forming the holes generally involves placing the plate against the appropriate vertebral bodies and using a guide to hold the proper angle with respect to the plate and bone as a drill is used. The difficulty in this process involves slippage at the interface between the unsecured plate and the bone. To avoid slippage, the surgeon is generally required to use, simultaneously, a plate holding mechanism, which may be removably affixed to the plate, to maintain the plate in its proper position, a drill guide to set the desired angulation (which is set by the thread angle of the plate), and the drill itself. It is understood that simultaneous manipulation of these three tools by the surgeon is tedious and difficult.
Therefore, there is a need for a new and novel cervical, thoracic, and/or lumbar screw plate assembly having a polyaxial coupling of the screw to the plate assembly, whereby a single plate assembly is compatible with a wide range of screw-in angles and a wide range of plate assembly lengths. There is also a need for a screw plate assembly having a flush exterior while being fixed to the vertebral bodies which it immobilizes, having no screw head protrusion despite non-perpendicular angulation. There is also a need for a spinal implant assembly which is more sturdy and more versatile than previous designs. There is also a need for a screw plate assembly which provides the surgeon with the greatest freedom to choose the most desirable angle in which to direct the bone screw. There is also a need for an orthopedic screw plate assembly which has a simple and effective locking mechanism for locking the bone screw to the plate assembly. There is also a need for an orthopedic screw plate assembly which has a simple and effective means of holding the plate assembly in position for the pre-drilling of screw holes.
The invention provides an orthopedic device including a longitudinal plate assembly having an adjustable length and two ends. Each of the ends includes a feature that can be used to couple the end to a body structure, such as, for example, a vertebral bone. Preferably, the assembly includes two longitudinal plates that can translate longitudinally with respect to one another through a plurality of positions and be secured with respect to one another at one of the positions, thereby enabling the length of the assembly to be adjusted. Inasmuch as the length of the plate assembly can be adjusted, the surgeon can set the length to the most clinically appropriate length for effective coupling of the plate assembly to the body structure or structures.
In an embodiment, the invention provides a plate assembly including a first longitudinal plate having an end defined by longitudinal prongs; a second longitudinal plate having a longitudinal bore, the longitudinal bore being adapted to receive the prongs for longitudinal translation therein through a plurality of positions; and a lock assembly for locking the prongs within the bore at one of the positions. Each plate comprises a feature that can be used to couple the plate to a body structure.
In an aspect, the bore has an inner surface and the lock assembly presses the prongs against the inner surface. Preferably, the prongs are laterally adjacent one another and the lock assembly separates the prongs to press them against the inner surface. The lock assembly can include a threaded bore and a set screw passing between the prongs and into the threaded bore. Alternatively, the lock assembly can include a cam that when placed in a first position, does not press the prongs against the inner surface, allowing the prongs to longitudinally translate freely within the bore through the plurality of positions, and when placed in a second position (e.g., rotated 90 degrees with respect to the first position), separates the prongs to press them against the inner surface, preventing longitudinal translation of the prongs within the bore.
In another aspect, a lateral curvature is imparted to the plate assembly. The lateral curvature is preferably contoured to the curved roughly cylindrical surface of the vertebral bodies to which it can be secured.
In yet another aspect, at least one of the features comprises a through hole. Preferably, each feature comprises a pair of through holes. Preferably, there are two threaded holes at each end of the plate assembly extending through the plate assembly, positioned so that they are aligned in pairs with the vertebral bodies to which the plate assembly is to be attached.
In this aspect, the assembly can further include a bone screw having a shaft that can be inserted into the through hole and into a bone. The shaft can be threaded to cooperate with the threading in the through holes. The threading and shaft portion of the bone screws may be of a variety of standard designs, or a particular design which may be found more secure than the standard ones. Preferably, the head is not standard in that it comprises a semi-spherical section.
In this aspect, the assembly can further include a coupling element that has a semi-spherical interior volume and that can be inserted into the through hole. The bone screw can have a semi-spherical head that can be rotationally freely mounted within the semi-spherical interior volume prior to insertion of the coupling element into the through hole. The shaft and the coupling element can be inserted into the through hole and the shaft can be inserted into the bone at a selected angle within a predetermined range of angles, including non-perpendicular angles, relative to the respective plate, thereby locking the coupling element and the head to the respective plate at the selected angle as the head and the coupling element are advanced into the through hole. For example, the first step in a process of implanting such an embodiment of the invention is to position the plate assembly against the vertebral bodies and to align the entry points for the screws. The next step in such a process is to pre-drill holes into the vertebral bones at desired angles, into which the screws will be inserted. With the plate assembly in place, the screws may be screwed into the drilled holes in the vertebral bodies.
In this aspect, the head of the bone screw can have a recess to which a screwdriving tool can be mated for inserting the screw into the through hole and into the bone. The recess can be a slot, phillips, star, hexagonal or other shape that is ideally suited for mating to an appropriate screwdriving tool. When the head of the bone screw is semi-spherical for use with a coupling element in the manner described above, however, the recess should not alter the semi-spherical shape of the head.
Accordingly, the coupling element can have a top surface recess through which the screwdriving tool may be inserted. The top surface recess can be aligned with the recess in the head of the bone screw. This allows the bone screw to be inserted into the bone using the screwdriver. Alternatively, instead of a recess, the coupling element may be partially opened so that the screw and the coupling may be manipulated easily so that the recess in the head of the screw is accessible. In either variation, once the screw has been fully inserted into the vertebral bone, at the desired angle, the coupling element, via its rotationally free mating of the socket to the inserted screw, is realigned so that it may be locked down into the plate assembly. Screwing down the coupling element provides the locking of the screw to the plate assembly, whereby the screw can be angled non-perpendicularly (or perpendicularly, if desired) with respect to the plate assembly, while the coupling element is flush with a bottom surface of one of the plates of the plate assembly, without the need for a set screw.
In this aspect, the interior semi-spherical interior volume of the coupling element can be defined by a curved interior surface which forms a receiving socket into which the semi-spherical head is inserted, whereby the head is rotationally freely mounted in the semi-spherical interior volume. The curved interior surface can include slots which permit the interior semi-spherical volume to expand to facilitate the insertion of the semi-spherical head of the bone screw therein. The through hole can be tapered inwardly to cause, upon insertion of the coupling element into the through hole, the slots to be compressed, which causes the curved interior surface to lock the semi-spherical head of the screw at a definite insertion angle. Therefore, the coupling element may be crush-locked to the head of the screw by the application of a radial force. The tapering has the effect of applying a radial force to the slotted socket portion of the coupling element. This circumferential reduction has the desirable effect of locking the screw at the insertion angle. In this way, the coupling element serves as an additional support for keeping the screw in the vertebral bone at the proper angle.
It is understood that variations in the coupling element (with respect to its recessed or open top) can be used without departing from the scope of the invention so that polyaxial screws may be used with cervical, thoracic, and lumbar plates, despite the considerable variation in plate thicknesses.
In still another aspect, at least one of the plates has a bottom surface and the assembly further includes at least one feature protruding from the bottom surface for removable and temporary fixation of the plate assembly to the body structure. Preferably, the feature comprises a spike. The spike can interface with the vertebral bones to hold the plate assembly in position during the pre-drilling step. For example, the plate assembly may be held firmly in place by simply positioning the plate assembly and applying enough pressure to drive the spikes into the vertebral bone. The spikes will hold the plate assembly in position, thereby freeing the hands of the surgeon to easily and accurately pre-drill the ideally angled holes. The spikes also provide supplementary gripping and holding strength for the plate assembly, in addition to the screws, once the plate assembly has been implanted securely.